Active Ingredient: Zanubrutinib
Zanubrutinib in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Oral, 320 milligrams zanubrutinib, once daily.
Regimen B: Oral, 160 milligrams zanubrutinib, 2 times daily.
The recommended total daily dose of zanubrutinib is 320 mg. The daily dose may be taken either once daily or divided into two doses of 160 mg twice daily. Treatment with zanubrutinib should be continued until disease progression or unacceptable toxicity.
Zanubrutinib must be administered orally before obinutuzumab infusion. The recommended dose is obinutuzumab 1,000 mg intravenously on Days 1, 8, and 15 of Cycle 1, and on Day 1 of every 28-day cycle from Cycles 2 to 6. At the discretion of the physician, obinutuzumab may be administered 100 mg on Day 1 and 900 mg on Day 2 of Cycle 1 instead of 1,000 mg on Day 1 of Cycle 1. Obinutuzumab maintenance (one infusion every two months for up to two years) may be prescribed. Refer to the obinutuzumab SmPC for additional dosing information, including premedication before each infusion.
Recommended dose modifications of zanubrutinib for Grade 3 or greater adverse reactions are provided in the following table.
Recommended dose modifications for adverse reactions:
| Adverse reaction | Adverse reaction occurrence | Dose modification (starting dose: 320 mg once daily or 160 mg twice daily) |
|---|---|---|
| ≥Grade 3 non-haematological toxicities Grade 3 febrile neutropenia Grade 3 thrombocytopenia with significant bleeding Grade 4 neutropenia (lasting >10 consecutive days) Grad 4 thrombocytopenia (lasting >10 consecutive days) | First | Interrupt zanubrutinib Once toxicity has resolved to ≤Grade 1 or baseline: Resume at 320 mg once daily or 160 mg twice daily |
| Second | Interrupt zanubrutinib Once toxicity has resolved to ≤Grade 1 or baseline: Resume at 160 mg once daily or 80 mg twice daily | |
| Third | Interrupt zanubrutinib Once toxicity has resolved to ≤Grade 1 or baseline: Resume at 80 mg once daily | |
| Fourth | Discontinue zanubrutinib |
Asymptomatic lymphocytosis should not be regarded as an adverse reaction, and these patients should continue taking zanubrutinib.
For dose modification of obinutuzumab for adverse reactions, refer to the SmPC of obinutuzumab.
A double dose should not be taken to make up for a forgotten dose. If a dose is not taken at the scheduled time, the next dose should be taken according to the normal schedule.
Zanubrutinib can be taken with or without food.
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